Pharmacokinetic and Pharmacodynamic Investigations of Fetal Anesthesia During Maternal Fetal Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Boston Children's Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Maximum plasma concentration (Cmax) of fetal anesthesia
Study Overview
Brief Summary
This study examines how three medications commonly used during fetal surgery, fentanyl, rocuronium, and atropine, behave in the fetus. The primary goal is to understand their pharmacokinetics (how the drugs are absorbed, distributed, and cleared), pharmacodynamics (how they affect fetal physiology), and how they transfer between mother and fetus through the placenta. The secondary goal is to measure drug levels in discarded fetal blood samples collected during clinically indicated procedures and relate those levels to fetal heart rate, heart rate variability, movement, gestational age, and fetal size. An optional maternal blood draw component will allow comparison of maternal and fetal drug concentrations to better understand placental transfer. The study does not change clinical care or require extra fetal procedures, and findings may help create safer, evidence-based fetal anesthesia dosing strategies tailored to gestational age.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Pregnant and undergoing maternal-fetal surgery requiring clinically indicated fetal anesthesia and planned fetal blood sampling as part of usual fetal care
- •Fetus is with or without congenital heart disease
Exclusion Criteria
- •Patient or fetus have any known liver or kidney disease
- •Patient or fetus has any known allergy to fentanyl, rocuronium, or atropine
- •Patient has taken inhibitors, inducers or substrates of CYP3A4 other than midazolam (including erythromycin, ranitidine, verapamil, antihistamines, and dextromethorphan) within 24 hours of surgery.
Arms & Interventions
Pregnant women undergoing maternal-fetal surgery
Pregnant women undergoing maternal-fetal surgery requiring fetal anesthesia. This study is purely observational.
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax) of fetal anesthesia
Time Frame: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the peak plasma concentration (Cmax) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
Area under the plasma concentration versus time curve (AUC) of fetal anesthesia
Time Frame: 2 years
Characterize the plasma concentrations / pharmacokinetics profile, specifically the area under the plasma concentration versus time curve (AUC) of commonly used fetal anesthetics, investigate the pharmacodynamic effects of anesthetics on fetus, assess the maternal-fetal transfer of anesthetics during surgery, and identify potential variations during different stages of fetal development.
Secondary Outcomes
- Maternal blood concentration of fetal anesthesia(2 years)
- Fetal blood concentration of maternal anesthesia(2 years)
Investigators
Gwen Owens
Instructor of Anesthesia, Harvard Medical School
Boston Children's Hospital
